Heron’s (HRTX) Sustol For Chemotherapy-Induced Nausea Approved By FDA In Third Attempt

The U.S. Food and Drug Administration finally approved Heron Therapeutics Inc.’s long-acting injection to prevent chemotherapy-induced nausea and vomiting that had previously been rejected two times.

There will be about 1,685,210 new cases of cancer in the United States in 2016, according to data from the American Cancer Society. Chemotherapy is the most commonly used and effective therapies for cancer patients.

The treatment, however, comes with a number of side effects. Nausea and vomiting are two of the most severe side effects and occur in almost 80 percent of the cases, Reuters reported National Institute of Health’s statistics. These effects are also the leading cause for patients discontinuing chemotherapy.

There exist chemotherapy-induced nausea and vomiting (CINV) treatments like Eisai’s Aloxi injection but they are only effective for a limited time of 48 hours or less. However, Heron said Wednesday that its Sustol could prevent the nausea and vomiting for five days.

The serotonin-3 (5-HT3) receptor plays a role in nausea and vomiting. Sustol and Aloxi both target this receptor to achieve the desired results.

“In our experience, other 5-HT3 receptor antagonists, including palonosetron, are generally effective for 48 hours or less,” Tech Times reported Ralph Boccia, medical director of Center for Cancer and Blood Disorders, saying. “Sustol, due to its extended-release profile, represents a novel option that can protect patients from CINV for a full 5 days.”

After postponing its decision the drug from January and late February, the FDA said in April that it found no deficiencies in Sustol’s marketing application. The approval came in combination with other agents that prevent CINV, except platinum-based regimens — reducing Sustol’s addressable population by about 7 percent, company executives told Reuters.

Sustol will be launched in the fourth quarter but Heron refrained from disclosing its price. The company said the pricing will be set after referencing other CINV treatments that have been approved recently.

Heron’s stock was up almost nine percent in morning trading Wednesday, but settled just above two percent in after hours of trading.